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NCT Number: NCT01824758

Effect of Esmolol on Pain Due to Rocuronium

90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.

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Key information

Conditions

Injection Site Irritation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

About this study

Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I and II patients
  • Undergoing general anesthesia for elective surgery

Exclusion criteria

  • Known allergy to esmolol or lidocaine
  • Chronic pain
  • Pregnancy
  • Withdrawal of consent by the patient

Treatment and study plan

Lidocaine

Drug

Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).

Other names: Aritmal, Jetmonal

esmolol

Drug

Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)

Other names: brevibloc

Rocuronium

Drug

0.05 mg/kg rocuronium

Placebo

Drug

Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)

Primary outcomes

  1. The injection pain due to rocuronium

    Time frame: 1 month

    Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

Secondary outcomes

  1. Score on pain due to injection of rocuronium

    Time frame: 1 month

    Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

Other outcomes

  1. To assess patient satisfaction

    Time frame: 1 Month

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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